Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000358044
Ethics application status
Approved
Date submitted
9/03/2010
Date registered
6/05/2010
Date last updated
25/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Sexually Transmitted Infections (STI) in Remote communities: ImproVed & Enhanced primary health care
Scientific title
Sexually Transmitted Infections (STI) in Remote communities: ImproVed & Enhanced primary health care - A randomised community trial to reduce STIs in remote Aboriginal and Torres Strait Islander communities, comparing clinical care enhanced with a Sexual Health Quality Improvement Program with standard clinical care
Secondary ID [1] 1554 0
None
Universal Trial Number (UTN)
Trial acronym
STRIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexually transmitted infections 243435 0
Condition category
Condition code
Infection 239739 239739 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, called the Sexual Health Quality Improvement Program will involve the following components:

1. Development of an action plan including goals and strategies to improve clinical service delivery for diagnosis and management of bacterial STIs to reach best practice targets. STRIVE Coordinators will meet with participating primary health services annually for a day to undertake a site assessment, develop an Action Plan tailored to the individual service and discuss goals and strategies for the Action Plan.

2. Six-monthly collaborative feedback meetings to discuss progress on the Action Plan. STRIVE Coordinators will meet with health service management to discuss the Action Plan and progress towards the goals and strategies developed.

3. Quantitative data reports will be provided to health services every 6 months showing progress towards best practice targets.

4. Training - STRIVE coordinators will provide staff with training in quality improvement and basic research skills and encourage further training in sexual health. Training requirements will be discussed at the collaborative feedback meetings.

5. Incentives payments based on progress towards the best practice targets. Opportunities exist for each health service to receive a total incentive payment of between $10,000 and $30,000 per year. Incentives will be calculated from the quantitative reports and will be paid 6 monthly.

Best practice episodes and targets:

Best practice episodes -
1. Offer STI screening to sexually active 14 - 34 year olds
2. Treat quickly a) Symptomatic STI infections - treat immediately b) Asymptomatic STI infections - treat within 7 days of the positive result being received from the laboratory
3. Test for re-infection at 3 months. For people with STI infection, follow up and test at 3 months after treatment
4. Contact referral. For people with STI infection, test and treat their partner/s

Best practice targets -
1. 80% of the resident population aged 16 - 34 tested annually
2. 95% of syndromically diagnosed infections treated immediately
3. 80% of asymptomatic STI infections - treated within 7 days of the positive result being recieved from the laboratory
4. 80% of STI infections - re-tested within 3 months of treatment
5. 50% of STI infections - the named sexual partner/s is documented to be treated within 14 days

The trial is cluster-randomised. The duration of the intervention will depend on when the cluster, in which the health service falls, is randomised. For clusters that are randomised in year 1, the intervention will continue for three years. For clusters randomised in year 2, the intervention will continue for 2 years. For clusters randomised in year 3, the intervention will continue for 1 year.
Intervention code [1] 237060 0
Prevention
Intervention code [2] 241197 0
Other interventions
Comparator / control treatment
Control trial sites will undergo standard STI care. Standard care is per the following clinical guidelines: For the Northern Territory - CARPA (Central Australian Rural Practitioners Association) Reference Manual 5th Edition, Minymaku Kutju Tjukurpa – Women's Business Manual 4th Edition. For Far North Queensland - The Primary Clinical Care Manual, the Queensland STI Clinical Guidelines, Clinical Practice Guidelines for Sexual and Reproductive Health Nursing Officers. For Western Australia - Guidelines for Managing Sexually Transmitted Infections - The Silver Book. These guidelines include screening, assessment, treatment, management, prevention and reporting recommendations. Clinicians are recommended to follow these guidelines on a case by case basis.
Control group
Active

Outcomes
Primary outcome [1] 240560 0
Best practice service delivery involving the diagnosis and treatment of the three STIs (chlamydia, gonorrhoea and trichomonas) in Aboriginal and/or Torres Strait Islander people, defined as: STI testing coverage, STI testing uptake, 3-month test for re-infection, time to treatment interval and named sexual contacts treated. This will be assessed by analysing results from health services' data reports. These data will indicate if health services have achieved the determined best practice service delivery levels.
Timepoint [1] 240560 0
Annually and at completion of the trial
Primary outcome [2] 258122 0
Prevalence of chlamydia, gonorrhoea or trichomonas among 16-34 year olds. This will be measured using an annual prevalence survey: 50 male and 50 female Aboriginal and/or Torres Strait Islanders aged 16 - 34 residing in each cluster will be opportunisitically tested when they present at the health service.
Timepoint [2] 258122 0
Annually and at completion of the trial
Secondary outcome [1] 257149 0
The profile of health services defined as the characteristics of the site, including STI management practices. This will be determined through the initial site assessment process, which will include collection of demographic information and a review of sexual health clinical care. The site assessment results will be analysed to create a de-identified profile of trial clusters.
Timepoint [1] 257149 0
At the completion of the trial
Secondary outcome [2] 257150 0
Barriers and motivators related to the uptake of STI clinical services. This will be assessed through qualitative and quantitative data from the health services and systems assessment questionnaires.
Timepoint [2] 257150 0
At the completion of the trial
Secondary outcome [3] 257151 0
Trial acceptability and transferability to health services staff and stakeholders. This will be assessed through qualitative interviews with key stakeholders and health service management and clinical staff.
Timepoint [3] 257151 0
At the completion of the trial
Secondary outcome [4] 257152 0
Non-trial events that have a potential to impact on the extent of STIs in trial clusters. STRIVE investigators will maintain a log of other sexual health activities occurring during STRIVE and will analyse this in relation to the potential impact on STIs.
Timepoint [4] 257152 0
At completion of the trial

Eligibility
Key inclusion criteria
Communities that meet the following criteria: - Considered remote by the Australian Bureau of Statistics (ABS) - With a resident population of at least 100 Aboriginal and/or Torres Strait Islander people aged 16 - 34 years - Community and health services willing and able to provide access to de-identified clinical data - Health services able to sustain data collection, consistent with trial protocol
Minimum age
16 Years
Maximum age
34 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Communities where there is a diverse range of health services that are accessed by Aboriginal and/or Torres Strait Islanders within the same location

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The trial is cluster randomised using a stepped-wedge design. The unit of randomisation is a geographic cluster. Each cluster includes at least one community and primary health service, and is defined by known social and cultural networks. The randomisation sequence for each trial clusters will be held by the statistician at the National Centre in Human Immunodeficiency Virus (HIV) Epidemiology and Clinical Research. When a trial cluster is ready for randomisation, the STRIVE coordinator will contact the statistician via email and the statistician will then inform the STRIVE coordinator if this clusters will receive the Sexual Health Quality Improvement Program or will be a control cluster.

Randomisation will occur over a period of three years. At the start of each year, seven of the trial clusters will be randomised to the intervention, the following year a further seven will be randomised, and in the third year, the final seven will be randomised such that by the end of the trial, all clusters will have received the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Geographical areas (trial clusters) will be randomised to the intervention or control strategies using a minimisation approach. This will maximise the balance across several baseline variables. These variables will include: - Estimated baseline STI prevalence in each geographical area; - Size - Geographical region - Prevalence The randomisation sequence will be generated at NCHECR once the estimated baseline STI prevalence and testing rates are available
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Community randomised, stepped wedge
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237483 0
Government body
Name [1] 237483 0
National Health and Medical Research Council (NHMRC)
Country [1] 237483 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
UNSW KENSINGTON CAMPUS
The University of New South Wales
SYDNEY
NSW 2052
Country
Australia
Secondary sponsor category [1] 237031 0
University
Name [1] 237031 0
Menzies School of Health Research, Charles Darwin University
Address [1] 237031 0
PO Box 41096
Casuarina NT 0811
Country [1] 237031 0
Australia
Other collaborator category [1] 831 0
Government body
Name [1] 831 0
Northern Territory (NT) Department of Health
Address [1] 831 0
87 Mitchell Street
Darwin NT 0800
Country [1] 831 0
Australia
Other collaborator category [2] 1179 0
Other Collaborative groups
Name [2] 1179 0
Central Australian Aboriginal Congress
Address [2] 1179 0
25 Gap Rd
Alice Springs NT 0870
Country [2] 1179 0
Australia
Other collaborator category [3] 1222 0
Other Collaborative groups
Name [3] 1222 0
Aboriginal Medical Services Alliance Northern Territory
Address [3] 1222 0
Tourism House
43 Mitchell Street
Darwin NT 0800
Country [3] 1222 0
Australia
Other collaborator category [4] 1223 0
Other Collaborative groups
Name [4] 1223 0
Apunipima Cape York Health Council Aboriginal Corporation
Address [4] 1223 0
186 McCoombe Street
Bungalow
Cairns QLD 4870
Country [4] 1223 0
Australia
Other collaborator category [5] 1224 0
Other Collaborative groups
Name [5] 1224 0
Kimberley Aboriginal Medical Services Council
Address [5] 1224 0
Corner of Anne and Dora Street
PO Box 1377
Broome WA 6725
Country [5] 1224 0
Australia
Other collaborator category [6] 1225 0
Government body
Name [6] 1225 0
Kimberley Population Health Unit
Address [6] 1225 0
Yamamoto House
Napier Terrace
Broome WA 6725
Country [6] 1225 0
Australia
Other collaborator category [7] 1226 0
Government body
Name [7] 1226 0
Cape York Health Service District
Address [7] 1226 0
Corner Northern and Central Avenue
Rocky Point
Weipa QLD 4874
Country [7] 1226 0
Australia
Other collaborator category [8] 1227 0
University
Name [8] 1227 0
University of South Australia
Address [8] 1227 0
GPO Box 2471
Adelaide SA 5001
Country [8] 1227 0
Australia
Other collaborator category [9] 277091 0
University
Name [9] 277091 0
The University of Melbourne
Address [9] 277091 0
The University of Melbourne
Victoria 3010
Country [9] 277091 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243883 0
Western Australian Aboriginal Health Information Ethics Committee
Ethics committee address [1] 243883 0
Ethics committee country [1] 243883 0
Australia
Date submitted for ethics approval [1] 243883 0
23/11/2009
Approval date [1] 243883 0
07/12/2009
Ethics approval number [1] 243883 0
EC00292
Ethics committee name [2] 258647 0
Cairns Base Hospital Ethics Committee
Ethics committee address [2] 258647 0
Ethics committee country [2] 258647 0
Australia
Date submitted for ethics approval [2] 258647 0
19/11/2009
Approval date [2] 258647 0
15/03/2010
Ethics approval number [2] 258647 0
EC00157
Ethics committee name [3] 258648 0
Central Australian Human Research Ethics Committee
Ethics committee address [3] 258648 0
Ethics committee country [3] 258648 0
Australia
Date submitted for ethics approval [3] 258648 0
12/11/2009
Approval date [3] 258648 0
30/03/2010
Ethics approval number [3] 258648 0
EC00155
Ethics committee name [4] 258649 0
Human Research Ethics Committee of Northern Territory Department of Health and Families and Menzies School of Health Research
Ethics committee address [4] 258649 0
Ethics committee country [4] 258649 0
Australia
Date submitted for ethics approval [4] 258649 0
18/11/2009
Approval date [4] 258649 0
20/03/2010
Ethics approval number [4] 258649 0
EC00153
Ethics committee name [5] 258650 0
Western Australian Country Health Service Board Research Ethics Committee
Ethics committee address [5] 258650 0
Ethics committee country [5] 258650 0
Australia
Date submitted for ethics approval [5] 258650 0
29/04/2010
Approval date [5] 258650 0
Ethics approval number [5] 258650 0
EC00261
Ethics committee name [6] 258891 0
University of New South Wales Human Research Ethics Committee (B)
Ethics committee address [6] 258891 0
Ethics committee country [6] 258891 0
Australia
Date submitted for ethics approval [6] 258891 0
06/04/2010
Approval date [6] 258891 0
12/04/2010
Ethics approval number [6] 258891 0
EC00153

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30001 0
Address 30001 0
Country 30001 0
Phone 30001 0
Fax 30001 0
Email 30001 0
Contact person for public queries
Name 13248 0
Mr James Ward
Address 13248 0
CFI Building, Corner West and Boundary Streets Darlinghurst NSW 2010
Country 13248 0
Australia
Phone 13248 0
+61 (0) 2 9385 0900
Fax 13248 0
Email 13248 0
[email protected]
Contact person for scientific queries
Name 4176 0
Professor John Kaldor
Address 4176 0
CFI Building, Corner West and Boundary Streets Darlinghurst NSW 2010
Country 4176 0
Australia
Phone 4176 0
+61 (0) 2 9385 0900
Fax 4176 0
Email 4176 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCoinfection with Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis: A crosssectional analysis of positivity and risk factors in remote Australian Aboriginal communities.2015https://dx.doi.org/10.1136/sextrans-2014-051535
EmbaseStrategies to improve control of sexually transmissible infections in remote Australian Aboriginal communities: a stepped-wedge, cluster-randomised trial.2019https://dx.doi.org/10.1016/S2214-109X%2819%2930411-5
N.B. These documents automatically identified may not have been verified by the study sponsor.